Difference between revisions of "User:Shawndouglas/sandbox/sublevel9"

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| text      = This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
| text      = This is sublevel9 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
}}
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==Sandbox begins below==
==Sandbox begins below==


==2. Sample Management==
[[File:|right|500px]]
{|
 
| STYLE="vertical-align:top;"|
'''Title''': ''LIMS Selection Guide for Materials Testing Laboratories''
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
 
|-
'''Edition''': First Edition
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
 
|-
'''Author for citation''': Shawn E. Douglas
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
'''Publication date''': ??? 2023
  | style="background-color:white;" |The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
 
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
Description goes here...
  | style="background-color:white;" |The system shall record the current and historical storage location for the laboratory's standards and reagents.
 
|-
The table of contents for ''LIMS Selection Guide for Materials Testing Laboratories'' is as follows:
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
 
  | style="background-color:white;" |The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
:[[User:Shawndouglas/sandbox/sublevel10|1. Introduction to materials and materials testing laboratories]]
|-
::1.1 Materials testing labs, then and now
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
:::1.1.1 Materials testing 2.0
  | style="background-color:white;" |The system shall require the recording of a standard and reagent's first opening date.
::1.2 Industries, products, and raw materials
|-
::1.3 Laboratory roles and activities in the industry
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
:::1.3.1 R&D roles and activities
  | style="background-color:white;" |The system shall allow only active standards and reagents to be shown as available for use.
:::1.3.2 Pre-manufacturing and manufacturing roles and activities
|-  
:::1.3.3 Post-production quality control and regulatory roles and activities
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
 
  | style="background-color:white;" |The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
:[[User:Shawndouglas/sandbox/sublevel11|2. Standards, regulations, and test methods affecting materials testing labs]]
|-  
::2.1 Globally recognized materials manufacturing standards
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-7]
:::2.1.1 American Society of Civil Engineers (ASCE) materials standards
  | style="background-color:white;" |The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
:::2.1.2 ASTM International Volume 15.04
|-  
:::2.1.3 Canadian Standards Association (CSA) A3000 series
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
:::2.1.4 International Organization for Standardization (ISO) 10993
  | style="background-color:white;" |The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
:::2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family
|-
::2.2 Regulations and laws around the world
  | style="padding:5px; width:500px;" |
:::2.2.1 21 CFR Part 175 and 176 - United States
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
:::2.2.2 Building Standard Law - Japan
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
:::2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
:::2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
:::2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1]<br />
::2.3 Standardized test methods for materials
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-9]
::2.4 Materials laboratory accreditation
  | style="background-color:white;" |The system should provide a means to manually or automatically track sample inventory amounts and status.
:::2.4.1 A note about engineering and construction materials testing
|-
 
  | style="padding:5px; width:500px;" |[[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-10]
:[[User:Shawndouglas/sandbox/sublevel12|3. Choosing laboratory informatics software for your materials testing lab]]
  | style="background-color:white;" |The system shall be able to link test methods and specifications to standards and reagents.
::3.1 Evaluation and selection
|-
:::3.1.1 Technology considerations
  | style="padding:5px; width:500px;" |
::::3.1.1.1 Laboratory informatics options
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
:::3.1.2 Features and functions
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
::::3.1.2.1 Base features
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
::::3.1.2.2 Specialty features
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
:::3.1.3 Cybersecurity considerations
[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
:::3.1.4 Regulatory compliance considerations
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
:::3.1.5 System flexibility
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
:::3.1.6 Cost considerations
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
::3.2 Implementation
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
:::3.2.1 Internal and external integrations
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
::3.3 MSW, updates, and other contracted services
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-11]<br />
::3.4 How a user requirements specification fits into the entire process (LIMSpec)
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
:[[User:Shawndouglas/sandbox/sublevel13|4. Resources for selecting and implementing informatics solutions]]
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
::4.1 LIMS vendors
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
::4.2 Consultants
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
::4.3 Professional
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
:::4.3.1 Trade organizations
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
:::4.3.2 Conferences and trade shows
  | style="background-color:white;" |The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
::4.4 LIMSpec
|-
 
|}
:[[User:Shawndouglas/sandbox/sublevel14|5. Taking the next step]]
|}
::5.1 Conduct initial research into a specification document tailored to your lab's needs
::5.2 Issue some of the specification as part of a request for information (RFI)
::5.3 Respond to or open dialogue with vendors
:::5.3.1 The value of demonstrations
::5.4 Finalize the requirements specification and choose a vendor
 
:[[User:Shawndouglas/sandbox/sublevel15|6. Closing remarks]]
 
:[[User:Shawndouglas/sandbox/sublevel16|Appendix 1. Blank LIMSpec template for manufacturing labs]]
::A1. Introduction and methodology
::A2. Primary laboratory workflow
::A3. Maintaining laboratory workflow and operations
::A4. Specialty laboratory functions
::A5. Technology and performance improvements
::A6. Security and integrity of systems and operations
::A7. Putting those requirements to practical use and caveats
::A8. LIMSpec in Microsoft Word format

Latest revision as of 23:14, 20 September 2023

This is sublevel9 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

[[File:|right|500px]]

Title: LIMS Selection Guide for Materials Testing Laboratories

Edition: First Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: ??? 2023


Description goes here...

The table of contents for LIMS Selection Guide for Materials Testing Laboratories is as follows:

1. Introduction to materials and materials testing laboratories
1.1 Materials testing labs, then and now
1.1.1 Materials testing 2.0
1.2 Industries, products, and raw materials
1.3 Laboratory roles and activities in the industry
1.3.1 R&D roles and activities
1.3.2 Pre-manufacturing and manufacturing roles and activities
1.3.3 Post-production quality control and regulatory roles and activities
2. Standards, regulations, and test methods affecting materials testing labs
2.1 Globally recognized materials manufacturing standards
2.1.1 American Society of Civil Engineers (ASCE) materials standards
2.1.2 ASTM International Volume 15.04
2.1.3 Canadian Standards Association (CSA) A3000 series
2.1.4 International Organization for Standardization (ISO) 10993
2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family
2.2 Regulations and laws around the world
2.2.1 21 CFR Part 175 and 176 - United States
2.2.2 Building Standard Law - Japan
2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom
2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia
2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada
2.3 Standardized test methods for materials
2.4 Materials laboratory accreditation
2.4.1 A note about engineering and construction materials testing
3. Choosing laboratory informatics software for your materials testing lab
3.1 Evaluation and selection
3.1.1 Technology considerations
3.1.1.1 Laboratory informatics options
3.1.2 Features and functions
3.1.2.1 Base features
3.1.2.2 Specialty features
3.1.3 Cybersecurity considerations
3.1.4 Regulatory compliance considerations
3.1.5 System flexibility
3.1.6 Cost considerations
3.2 Implementation
3.2.1 Internal and external integrations
3.3 MSW, updates, and other contracted services
3.4 How a user requirements specification fits into the entire process (LIMSpec)
4. Resources for selecting and implementing informatics solutions
4.1 LIMS vendors
4.2 Consultants
4.3 Professional
4.3.1 Trade organizations
4.3.2 Conferences and trade shows
4.4 LIMSpec
5. Taking the next step
5.1 Conduct initial research into a specification document tailored to your lab's needs
5.2 Issue some of the specification as part of a request for information (RFI)
5.3 Respond to or open dialogue with vendors
5.3.1 The value of demonstrations
5.4 Finalize the requirements specification and choose a vendor
6. Closing remarks
Appendix 1. Blank LIMSpec template for manufacturing labs
A1. Introduction and methodology
A2. Primary laboratory workflow
A3. Maintaining laboratory workflow and operations
A4. Specialty laboratory functions
A5. Technology and performance improvements
A6. Security and integrity of systems and operations
A7. Putting those requirements to practical use and caveats
A8. LIMSpec in Microsoft Word format
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